Accredited Third Party IEC 60601 Testing for Medical Devices

Ensuring the safety and compliance of medical devices is crucial. Our comprehensive IEC 60601 testing services are designed to meet the stringent requirements of regulatory bodies.

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IEC 60601 Testing for Medical Devices

Ensuring the safety and compliance of medical devices is crucial. Our comprehensive IEC 60601 testing services are designed to meet the stringent requirements of regulatory bodies. From initial design to final product, we provide thorough medical devices testing to ensure your product meets all necessary standards.

510(k) Testing for Medical Devices

Navigating the regulatory landscape for medical devices can be challenging. Our 510(k) testing for medical devices simplifies this process, ensuring that your product meets FDA standards. Our team of experts will guide you through each step, ensuring that your device is compliant and market-ready.

FDA Testing Services

FDA testing is a critical component in bringing medical devices to market in the United States. We offer robust FDA testing services that cover all necessary requirements, ensuring your medical device meets the highest standards of safety and efficacy.

Health Canada Testing Services

For medical devices entering the Canadian market, Health Canada testing is essential. Our comprehensive testing services ensure your product complies with all Health Canada regulations, facilitating a smooth approval process and successful market entry.

How Can Megalab Help?

By integrating these key services—IEC 60601 testing, 510(k) testing, FDA testing, and Health Canada testing—we provide a one-stop solution for all your medical device testing needs. Ensure your products are safe, compliant, and ready for global markets with our expert testing services.

MegaLab is your partner in navigating and complying with these crucial standards to ensure your medical devices meet international requirements.

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International Medical Device Standards

Key Standards:

  • IEC 60601-1: General standard for medical electrical equipment.
  • IEC 60601-1-11: For home-use medical equipment.
  • IEC 60601-2-47: For ambulatory ECGs.

MegaLab offers comprehensive support for these and many other standards.

Historical Context and Specialized Standards:

  • IEC 60601-1-1: Addressed medical electrical systems, now integrated into IEC 60601-1 third edition.
  • IEC 60601-1-2:2007: EMC requirements for medical equipment, ensuring compliance with the EMC Directive.
  • IEC 60601-1-3:2008: Radiation protection in diagnostic X-ray equipment to minimize stray radiation exposure.
  • IEC 60601-1-4: Formerly dealt with Programmable Electrical Medical Systems (PEMS), now part of IEC 60601-1 third edition.
  • IEC 60601-1-8:2007: Guidelines for managing alarm systems in medical equipment.
  • IEC 60601-1-9:2008: Focuses on environmentally conscious design.
  • IEC 60601-1-10:2008: Standards for Physiologic Closed Loop Controllers.
  • IEC 60601-1-6:2010: Emphasizes usability in design to prevent user errors.
  • IEC 60601-1-11:2010: Standards for home healthcare equipment.

Risk Management and Usability:

  • ISO 14971: Risk management for medical devices.
  • MegaLab is highly qualified to evaluate and consult on your risk management file.
  • Start risk management from day one of your device design.

IEC 62366: Usability engineering for medical devices.

  • MegaLab can help review and build a usability file from scratch.

Software Lifecycle:

  • IEC 62304: Software lifecycle processes.
  • MegaLab ensures your software complies with the 62304 standard.